Bioequivalence of Fluconazole Capsules in Healthy Volunteers

Objective: To evaluate the bioavailability and bioequivalence between two kinds of fluconazole capsules. Methods: A single oral dose of fluconazole capsules of test and reference preparations were given respectively to 22 healthy male volunteers in a self random two-way cross over design and serum concentration was determined by HPLC. Results: The main pharmacokinetic parameters of test preparation and reference preparation were as follows: Cmax(7.13 ± 1.34),(6.72 ± 1.13)mg·L -1; tmax(0.84 ± 0.76),(1.04 ± 0.91)h; t1/2(ke()25.93 ± 4.33),(25.93 ± 5.70)h; AUC0(-t212.47 ± 29.54),(208.80 ± 31.56)mg·h·L -1; AUC0-∞ (224.74 ± 30.99),(221.79 ± 32.46)mg·h·L-1, respectively. F0-t and F0-∞ of test preparation were(102.53 ± 11.04)%,(102.03 ± 10.95)%, respectively. Conclusion: The test preparation is bioequivalent to the reference preparation.